On August 2, 2005, CIRCARE testified before the Secretary's Advisory Committee in a special session dedicated to advocates and representatives of research subjects and those concerned with the ethical conduct of research.

CIRCARE had previously requested broader representation so that SACHRP might hear not only from academic and industry representatives, but also from organizations representing the perspective of research subjects broadly defined. The Office for Human Research Protections (OHRP) and SACHRP did a commendable job of selecting lively, interesting speakers representing a wide range of constituencies.

Our presentation was delivered by CIRCARE Vice President Paul Gelsinger. He maintained the system of research oversight, largely by Institutional Review Boards (IRBs), is inadequate, full of gaps, riddled with conflict of interest, and lacking in systematic reporting of adverse events. The 25 million Americans who serve as human subjects each year deserve better.

In response to a question by SACHRP Chairman Ernest Prentice challenging the basis on which he characterized the system as ineffective, Paul replied that reform has happened only in response to crisis, or after reports of harm. As a result, increased oversight and reform has only been undertaken by a handful of IRBs at research institutions after disaster or in the wake of threatened or actual suspension by OHRP.

It's estimated there are somewhere between 4,000 to 8,000 IRBs in the U.S. While the exact number is unknown, many are inadequate to the task. Research with animals is regulated by law regardless of the source of funding, and has been so since the 1966 Animal Welfare Act. On the other hand, research with human subjects is only subject to regulation under the Common Rule when federal funds are involved, or when institutions choose to extend the Common Rule to all research covered by their Federal Wide Assurance. Research testing products subject to FDA IND or IDE regulation often overlaps, but this still leaves much research unregulated. At the behest of Chairman Prentice, CIRCARE founder Dr. Adil Shamoo estimated that at least 30% of all studies with human subjects are not covered by any regulation.

We reiterated our call for the enactment of a National Human Research Protection Act, which would cover all human subjects in research regardless of source of funding.

We look forward to the forthcoming HHS initiative requiring IRB registration, and suggest that enumeration of IRBs is woefully overdue. We hope that registration will afford an opportunity to evaluate the effectiveness of IRBs to protect humans in research. It's incumbent on us to protect the heroes who volunteer in research to benefit society.

We compliment the committee on their effort to hear from more diverse voices, and challenge them to integrate organizations that represent the research subject and advocate for their protection in an ongoing and substantive way.

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